Develops, validates, and maintains SAS deliverables for clinical study analysis and regulatory reporting. Creates SDTM and ADaM datasets, specifications, tables, listings, figures, and submission documentation. Performs quality control, resolves data issues, ensures CDISC and regulatory compliance, maintains audit-ready records, and communicates project status, risks, and timelines to cross-functional stakeholders.
Position Summary:
The Statistical Programmer Contractor is responsible for developing, validating, and maintaining SAS programming deliverables to support clinical study analysis and reporting. This role collaborates closely with Biostatistics and other cross-functional team members to produce high-quality, compliant datasets, tables, listings, and figures while ensuring adherence to project timelines, SOPs, regulatory requirements, and CDISC standards.
Responsibilities:
- Program and validate tables, listings, figures, and derived datasets using SAS.
- Develop SDTM and ADaM specs, datasets, and supporting documentation.
- Prepare and review mapping specifications, annotated case report forms (aCRF), define, SDRG, ADRG and other files needed in the submission.
- Perform quality control and validation activities for all programming deliverables.
- Collaborate with study team members to identify, investigate, and resolve data and output issues.
- Review study documents and provide input to improve programming quality, efficiency, and consistency.
- Maintain complete, accurate, and audit-/inspection-ready programming documentation.
- Communicate project status, risks, issues, and timeline impacts clearly to stakeholders.
- Other as assigned.
Qualifications:
- Bachelor’s degree required; Master’s degree preferred in Statistics, Biostatistics, Mathematics, Computer Science, or a related field.
- Minimum of 10 years of relevant statistical programming experience within the pharmaceutical, biotechnology, or CRO industry.
- Phase 3 and regulatory submission experience preferred.
- Strong SAS programming skills, with experience developing SDTM, ADaM, tables, listings, and figures.
- Strong knowledge of clinical trial processes, regulatory requirements, and programming documentation.
- High attention to detail, with strong analytical, problem-solving, and communication skills.
- Ability to work independently and manage multiple priorities in a deadline-driven environment.
ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.
Similar Jobs
Biotech
Develops, validates, and maintains SAS programming deliverables for clinical study analysis and regulatory reporting. Creates SDTM and ADaM datasets, tables, listings, figures, specifications, and submission documentation. Performs quality control, resolves data and output issues, maintains audit-ready records, and collaborates with Biostatistics and cross-functional study teams while managing timelines, risks, and compliance with SOPs, regulations, and CDISC standards.
Top Skills:
AdamCdiscSASSdtm
Cloud • Information Technology • Security • Software • Cybersecurity
Leads the West, Rockies, and North Central SLED sales team, driving performance, coaching sales excellence, building successful teams, and managing territory planning, assessment, and resource allocation. The role requires extensive SLED software/SaaS leadership experience, enterprise security knowledge, and the ability to position AI-driven solutions and lead scalable organizational change.
Top Skills:
Ai/MlCloud SecuritySaaSSaseZero Trust
Fintech
Partners with business leaders and HR centers of excellence to align human capital strategy with business goals. Provides coaching on employee relations, performance management, compensation, recruiting, talent development, succession planning, and organizational design. Investigates complex employee issues, mitigates legal and reputational risk, analyzes workforce trends, supports compensation reviews, and drives HR transformation and process improvements. Manages a program or specialty area while coaching and supporting team members.
Top Skills:
Human Resource Information Systems (Hris)Paylocity Performance Management
What you need to know about the Charlotte Tech Scene
Ranked among the hottest tech cities in 2024 by CompTIA, Charlotte is quickly cementing its place as a major U.S. tech hub. Home to more than 90,000 tech workers, the city’s ecosystem is primed for continued growth, fueled by billions in annual funding from heavyweights like Microsoft and RevTech Labs, which has created thousands of fintech jobs and made the city a go-to for tech pros looking for their next big opportunity.
Key Facts About Charlotte Tech
- Number of Tech Workers: 90,859; 6.5% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Lowe’s, Bank of America, TIAA, Microsoft, Honeywell
- Key Industries: Fintech, artificial intelligence, cybersecurity, cloud computing, e-commerce
- Funding Landscape: $3.1 billion in venture capital funding in 2024 (CED)
- Notable Investors: Microsoft, Google, Falfurrias Management Partners, RevTech Labs Foundation
- Research Centers and Universities: University of North Carolina at Charlotte, Northeastern University, North Carolina Research Campus
